Z-0965-2019Class II

Monaco Radiation Treatment Planning (RTP) System

Name: Z-0965-2019 Monaco Radiation Treatment Planning (RTP) System
Creator: Elekta, Inc.
Published: 2019-02-08
License: https://open.fda.gov/license/

Elekta Limited / initiated 2019-02-08 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of Monaco Radiation Treatment Planning (RTP) System on 2019-02-08. FDA classified it as Class II and gives the reason as "If Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco will automatically use this optimization model again when proceeding with the online plan adaptation of a completion...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0965-2019
Classification: Class II
Status: Terminated
Initiated: 2019-02-08
Posted: 2019-02-27
Terminated: 2024-08-19
Recalling firm: Elekta Limited
Product: Monaco Radiation Treatment Planning (RTP) System
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: If Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco will automatically use this optimization model again when proceeding with the online plan adaptation of a completion plan when it should not.
Root cause tag: software
FDA root cause: Software design
Action: Elekta notified customers on about 2/08/2019 via "URGENT IMPORTANT FIELD SAFETY NOTIFICATION." Instructions included to ensure the optimization model is set to "Reproduce Goal Dose" when creating a completion plan. Customers were also requested to post the recall notice in an accessible place for all users to see, advise the appropriate personnel working with the device of the recall, and to complete and return the Acknowledgement Form. The issue will be resolved in Monaco release 5.40.01.
Quantity in commerce: 14 devices
Distribution: Domestic distribution to Wisconsin, Texas. International distribution to Denmark, England, Germany, Netherlands, Sweden.
Product codes and lots: Software version 5.40

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0965-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0965-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-27

Product code MUJ

K183037Class IIMonaco RTP SystemElekta, Inc. / cleared 2018-12-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)